Study on the Safety and Effectiveness of Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called filgotinib on certain rare diseases that involve inflammation caused by the immune system. The diseases being studied are Idiopathic Inflammatory Myopathies, Behçet’s disease, and IgG4-related disease. These conditions are characterized by the body’s immune system mistakenly attacking its own tissues, leading to inflammation and various symptoms. The medication being tested, filgotinib, is a type of drug known as a JAK-inhibitor, which works by blocking specific pathways in the immune system that contribute to inflammation.

The purpose of this study is to examine the safety and effectiveness of filgotinib in patients whose symptoms have not improved with standard treatments. Participants in the study will receive either Jyseleca 100 mg or Jyseleca 200 mg film-coated tablets, which contain the active substance filgotinib. The study will last for a period of up to 26 weeks, during which participants will take the medication orally. Some participants may receive a placebo instead of the active medication. Throughout the study, participants will be monitored to assess how well the medication is working and to check for any side effects.

By participating in this study, researchers hope to gather valuable information about the potential benefits and risks of using filgotinib for treating these rare inflammatory diseases. The findings from this study could help improve treatment options for patients with these conditions in the future.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as age and medical history. A thorough review of your current health status is conducted.

A series of tests may be performed to ensure there is no active or latent tuberculosis infection. This includes a blood test and possibly a chest X-ray.

2 medication administration

The study involves taking a medication called filgotinib, which is available in two dosages: Jyseleca 100 mg and Jyseleca 200 mg. The medication is taken orally in the form of film-coated tablets.

The dosage and frequency of administration are determined by the study protocol and your specific condition. This information will be provided to you by the study team.

3 regular follow-up visits

Regular follow-up visits are scheduled to monitor your health and the effects of the medication. These visits may include physical examinations, blood tests, and other assessments as needed.

During these visits, you will be asked to complete various forms and questionnaires to evaluate your symptoms and overall well-being.

4 completion of study

At the end of the study period, a final visit is conducted. This visit includes a comprehensive evaluation of your health and any changes that have occurred during the study.

You will be asked to return any unused medication and provide feedback on your experience throughout the trial.

Who Can Join the Study?

Must be 18 years or older.
Must have a refractory disease, which means the disease continues to show symptoms even after trying a 12-week treatment with corticoids and not responding to at least prednisone and one other medication like methotrexate (MTX), mycophenolate mofetil (MMF), azathioprine (AZA), or rituximab, or cannot tolerate standard treatments as determined by the doctor.
Must have no evidence of active or latent tuberculosis (TB), which is a type of bacterial infection. This is confirmed by:
- A negative QuantiFERON-TB Gold test within 3 months before screening. If you have had a Bacille Calmette Guerin (BCG) vaccination, this test will still be used.
- No signs of active TB infection as determined by a qualified radiologist or lung specialist.
- No history of untreated or inadequately treated TB infection. If you have been treated adequately for TB in the past, a chest X-ray is required if not done in the last three months.
Must have one of the following conditions:
- Behçet’s disease with active symptoms but not life-threatening, with a BDCAF score indicating active disease or needing new or additional medication.
- Idiopathic inflammatory myopathy with active disease, shown by a CDASI score of 5 or higher, or abnormal levels of certain enzymes, or MRI showing active inflammation, or needing new or additional medication.
- IgG4-related disease with active disease, shown by a responder index score greater than 10 or needing new or additional medication.

Who Cannot Join the Study?

Patients with active infections cannot participate. This means if you currently have an infection that is not under control, you are not eligible.
Patients who have had a serious allergic reaction to similar medications in the past are excluded. A serious allergic reaction is one that required medical treatment or hospitalization.
Patients with severe liver disease are not eligible. This refers to significant liver problems that affect its function.
Patients with uncontrolled high blood pressure cannot join. This means if your blood pressure is not managed with medication or lifestyle changes, you are not eligible.
Patients with certain types of cancer are excluded. This refers to active cancer or cancer treatment within the last five years, except for some skin cancers.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of the mother and child.
Patients who have participated in another clinical trial within the last 30 days are not eligible. This is to avoid interference between different treatments.
Patients with severe heart disease are excluded. This refers to significant heart problems that affect its function.
Patients with severe kidney disease cannot join. This means significant kidney problems that affect its function.
Patients with autoimmune diseases other than the ones being studied are excluded. Autoimmune diseases are conditions where the immune system attacks the body.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Admfexizl Uzf	Amsterdam	The Netherlands
Ekyivwp Uzgghbkdqrdw Mrhqrhh Coaoaox Reogssksd (hfccwnu Maq	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.04.2023

Trial locations

Investigated drugs:

Filgotinib

Filgotinib is a medication that is being studied for its potential to help people with certain rare inflammatory diseases. It works by blocking specific proteins in the body that are involved in causing inflammation. This can help reduce symptoms like pain and swelling in conditions that are difficult to treat with other medications. In this clinical trial, researchers are looking at how safe and effective filgotinib is for patients who have not responded well to other treatments for their inflammatory diseases.

Investigated diseases:

Idiopathic Inflammatory Myopathies – These are a group of disorders characterized by muscle inflammation and weakness. The exact cause is unknown, but they are believed to involve the immune system attacking the muscles. Symptoms often begin with muscle weakness, particularly in the shoulders and hips, making it difficult to perform everyday tasks. Over time, the weakness can progress, affecting other muscles and leading to difficulties in swallowing or breathing. Muscle pain and tenderness may also occur. The progression can vary greatly among individuals, with some experiencing rapid onset and others a more gradual development.

Behçet’s Disease – This is a rare, chronic condition that causes inflammation of the blood vessels throughout the body. It often begins with painful mouth sores, similar to canker sores, and can progress to include genital sores, skin rashes, and eye inflammation. Joint pain and swelling, as well as gastrointestinal and neurological symptoms, may also develop. The disease can cause periods of flare-ups followed by remission. The severity and progression of symptoms can vary widely among individuals. It is considered an autoimmune disorder, where the body’s immune system mistakenly attacks its own tissues.

IgG4-related Disease – This is a chronic inflammatory condition characterized by tissue infiltration with IgG4-positive plasma cells. It can affect multiple organs, including the pancreas, salivary glands, and kidneys, leading to organ enlargement and dysfunction. The disease often begins with symptoms related to the affected organ, such as abdominal pain or swelling. Over time, it can cause the formation of masses or lesions in the affected tissues. The progression can vary, with some individuals experiencing mild symptoms and others developing significant organ damage. It is considered an immune-mediated condition, with the immune system playing a key role in its development.

Trial ID:

2022-502968-20-01

Protocol code:

2022-502968-20-00

Trial Phase:

Therapeutic exploratory (Phase II)

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